Polish Registry of Diabetes (PolReD)

Condition(s) studied

Investigational drug(s) / intervention(s)

Observational study - registry: Observational study - registry

Study summary

The aim of this project is to create a registry of diabetic patients, containing a detailed clinical profile of each patient, along with omics data, which will be analyzed using artificial intelligence algorithms, and their results will be implemented in the form of new recommendations of care for high-risk patients and those already suffering from diabetes.

The study will be conducted prospectively. The project participants will be patients with diabetes, patients at high risk of developing diabetes and a control group of normoglycemic patients who will participate in study visits at the Clinical Research Center of the Medical University of Bialystok.

Eligibility

Primary outcome measure(s)

• HbA1c — every 5 years
  Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
• Fasting glucose — every 5 years
  Fasting glucose concentration measured in plasma using the colorimetric method
• 2-hour glucose — every 5 years
  Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method - only in non-diabetic subjects
• Fasting insulin — every 5 years
  Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
• Lean body mass — every 5 years
  Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
• Fat mass — every 5 years
  Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
• Visceral Adipose Tissue mass — every 5 years
  Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
• Weight — every 5 years
  Total body weight measured using standardized scale
• Homeostatic model assessment for insulin resistance (HOMA-IR) — every 5 years
  Homeostatic model assessment for insulin resistance
• Homeostatic model assessment of beta cell function (HOMA-beta) — every 5 years
  Homeostatic model assessment of beta cell function
• VO2max — every 5 years
  Maximal oxygen consumption measured during cardio-pulmonary exercise test
• Triglycerides (TG) — every 5 years
  Serum triglycerides concentration measured using colorimetric method
• High-density lipoprotein cholesterol (HDL) — every 5 years
  Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric meth
• Low-density lipoprotein cholesterol (LDL) — every 5 years
  Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
• Total cholesterol — every 5 years
  Serum total cholesterol concentration measured using colorimetric method
• Plasma metabolome — every 5 years
  plasma metabolites concentrations measured using untargeted metabolomics
• Skeletal muscle transcriptome — every 5 years
  skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
• Skeletal muscle metabolome — every 5 years
  skeletal muscle metabolites concentrations measured using untargeted metabolomics
• Plasma microRNAs — every 5 years
  Expression of circulating smallRNA

Trial sites (1)

More Medical University of Bialystok trials in Poland

Other trials for the same condition